RECRUITING

A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN

Official Title

A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)

Quick Facts

Study Start:2025-08-25
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07096843

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of PMN with positive anti-PLA2R antibodies
  2. * CD19+ B cell count ≥40 cells/μL
  3. * UPCR ≥2.0 g/g
  4. * eGFR ≥40 mL/min/1.73 m²
  5. * Stable RAAS inhibitor therapy
  6. * Blood pressure \<150/90 mmHg at baseline
  7. * Adequate hematologic, hepatic, and renal function
  8. * Willing to use effective contraception (both sexes)
  9. * Other inclusion criteria may apply
  1. * Secondary Membranous Nephropathy
  2. * Rapidly progressive glomerulonephritis or other glomerulopathies
  3. * Prior B cell-depleting therapy within 24 weeks
  4. * Recent use of immunosuppressants
  5. * Active or high-risk infections
  6. * History of malignancy
  7. * Pregnancy or breastfeeding
  8. * Recent major surgery or hospitalization
  9. * Other exclusion criteria may apply

Contacts and Locations

Study Contact

Climb Bio Study Director
CONTACT
+1 866 857 2596
clinicaltrials@climbbio.com

Study Locations (Sites)

Climb Bio Investigative Site #110
Denver, Colorado, 80220
United States
Climb Bio Investigative Site #105
Orlando, Florida, 32086
United States
Climb Bio Investigative Site #108
Atlanta, Georgia, 30342
United States
Climb Bio Investigative Site #106
Indianapolis, Indiana, 46268
United States
Climb Bio Investigative Site #109
City of Saint Peters, Missouri, 63376
United States
Climb Bio Investigative Site #101
Clifton Park, New York, 12065
United States
Climb Bio Investigative Site #102
Philadelphia, Pennsylvania, 19104
United States
Climb Bio Investigative Site #104
Sherman, Texas, 75092
United States

Collaborators and Investigators

Sponsor: Climb Bio, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-25
Study Completion Date2027-10

Study Record Updates

Study Start Date2025-08-25
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • PMN
  • Anti-CD19
  • PrisMN

Additional Relevant MeSH Terms

  • Primary Membranous Nephropathy